Notices. Notice

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BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2007 ACTION: Notice. SUMMARY: This notice announces the annual adjustment in the amount in controversy

(AIC)threshold amounts for administrative law judge

(ALJ)hearings and judicial review under the Medicare appeals process. The adjustments to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2007. The 2007 AIC threshold amounts are $110 for ALJ hearings and $1,130 for judicial review. DATES: *Effective Date:* January 1, 2007. FOR FURTHER INFORMATION CONTACT: Michael L. Lipinski, Office of Medicare Hearings and Appeals, Office of the Secretary;

(216)615-4084. SUPPLEMENTARY INFORMATION: I. Background Section 1869(b)(1)(E) of the Social Security Act, as amended by Section 521 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the AIC threshold amounts for ALJ hearing requests and judicial review at $100 and $1000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Modernization Act “MMA”), amended section 1869(b)(1)(E) to require the AIC threshold amounts for ALJ hearings and judicial review be adjusted annually. The AIC threshold amounts are to be adjusted, as of January 2005, by the percentage increase in the medical care component of the consumer price index for all urban consumers (U.S. city average) for July 2003 to the July of the preceding year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C (Medicare Advantage “MA”) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals. A. Medicare Part A and Part B Appeals The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Social Security Act [42 U.S.C. 1395ff(b)(1)(E)], is included in the applicable implementing regulations, 42 CFR part 405, subpart I, at § 405.1006(b). The regulations require the Secretary of the Department of Health and Human Services (the Secretary) to publish changes to the AIC threshold amounts in the **Federal Register** . 42 CFR 405.1006(b)(2). In order to be entitled to a hearing before an ALJ, a party to a proceeding must meet the AIC requirement. 42 CFR 405.1006(c). Similarly, a party must meet the AIC requirement at the time judicial review is requested for the court to have jurisdiction over the appeal. 42 CFR 405.1136(a). B. Medicare Part C (Medicare Advantage) Appeals Section 940(b)(2) of the MMA applies the AIC adjustment requirement to Part C

(MA)appeals by amending section 1852(g)(5) of the Social Security Act [42 U.S.C. §§ 1395w-22(g)(5)]. The implementing regulations for Medicare Part C appeals are found at 42 CFR part 422, subpart M. Specifically, sections 422.600 and 422.612 discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 422.600 grants any party, except the MA organization, a right to an ALJ hearing as long as the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary. Section 422.612 states that any party, including the MA organization, may request judicial review if the amount in controversy meets the threshold requirement established annually by the Secretary. C. Health Maintenance Organizations, Competitive Medical Plans, and Health Care Prepayment Plans Section 940(b)(2) of the MMA also amended section 1876(c)(5)(B) of the Social Security Act [42 U.S.C. 1395ff(c)(5)(B)] to make section 1869(b)(1)(E) applicable to certain beneficiary appeals within the context of health maintenance organizations and competitive medical plans. The applicable implementing regulations for Medicare Part C appeals set forth in subpart M of 42 CFR part 422 and discussed above, apply to these appeals. The Medicare Part C appeals rules also apply to health care prepayment plan appeals. D. Medicare Part D (Prescription Drug Plan) Appeals The annually adjusted AIC threshold amounts for ALJ hearings and judicial review that apply to Medicare Parts A, B, and C appeals also apply to Medicare Part D appeals. Section 101 of the MMA added section 1860D-4(h)(1) regarding Part D appeals to the Social Security Act [42 U.S.C. 1395w-104(h)(1)]. This statutory provision requires a prescription drug plan sponsor to meet the requirements set forth in sections 1852(g)(4) and (g)(5) of the Social Security Act [42 U.S.C. 1395w-22(g)(4), (g)(5)] in a similar manner as MA organizations. As noted above, the annually adjusted AIC threshold requirement was added to section 1852(g)(5) by section 940(b)(2)(A) of the MMA. The implementing regulations for Medicare Part D appeals can be found at 42 CFR part 423, subpart M. The regulations impart at section 423.562(c) that unless the Part D appeals rules provide otherwise, the Part C appeals rules (including the annually adjusted AIC threshold amount) apply to Part D appeals to the extent they are appropriate. More specifically, §§ 423.610 and 423.630 of the Part D appeals rules discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 423.610(a) grants a Part D enrollee, who is dissatisfied with the Independent Review Entity

(IRE)reconsideration determination, a right to an ALJ hearing if the amount remaining in controversy after the IRE reconsideration meets the threshold amount established annually by the Secretary. Section 423.630(a) allows a Part D enrollee to request judicial review if the AIC meets the threshold amount established annually by the Secretary. II. AIC Adjustment Formula and AIC Adjustments As previously noted, section 940 of the MMA requires that the AIC threshold amounts be adjusted annually, beginning in January of 2005, by the percentage increase in the medical care component of the consumer price index

(CPI)for all urban consumers (U.S. city average) for July 2003 to the July of the preceding year involved and rounded to the nearest multiple of $10. A. Calendar Year 2005 The AIC threshold amount for ALJ hearing requests remained at $100 and the AIC threshold amount for judicial review rose to $1,050 for the 2005 calendar year. The 2005 AIC threshold amounts were published in the preamble to the Interim Final Rule, 70 FR 11420, 11423 (March 8, 2005), titled “Medicare Program: Changes to the Medicare Claims Appeal Procedures.” In addition, this information was previously made available to the public through a change to the Medicare Claims Processing Manual. CMS Change Request 3127, Revisions and Corrections to Chapter 29 of the IOM, Claims Processing Manual—Appeals § 30.8 (Nov. 26, 2004). B. Calendar Year 2006 The AIC threshold amount for ALJ hearing requests rose to $110 and the AIC threshold amount for judicial review rose to $1,090 for the 2006 calendar year. The 2006 AIC threshold amounts were published by Notice in the **Federal Register** , 71 FR 2247 (Jan. 13, 2006). C. Calendar Year 2007 The AIC threshold amount for ALJ hearing requests will remain at $110 and the AIC threshold amount for judicial review will rise to $1,130 for the 2007 calendar year. These new amounts are based on the 13.2 percent increase in the medical care component of the CPI from July of 2003 to July of 2006. The CPI level was at 297.6 in July of 2003 and rose to 337.0 in July of 2006. This change accounted for the 13.2 percent increase. The AIC threshold amount for ALJ hearing requests changes to $113.20 based on the 13.2 percent increase. In accordance with section 940 of the MMA, this amount is rounded to the nearest multiple of $10. Therefore, the 2007 AIC threshold amount for ALJ hearings is $110. The AIC threshold amount for judicial review changes to $1,132 based on the 13.2 percent increase. This amount was rounded to the nearest multiple of $10, resulting in a 2007 AIC threshold amount of $1,130. D. Summary Table of Adjustments in the AIC Threshold Amounts Table 1.—Amount-in-Controversy Threshold Amounts CY 2004 CY 2005 CY 2006 CY 2007 ALJ Hearing $100 $100 $110 $110 Judicial Review 1000 1050 1090 1130 CY—Calendar Year. Dated: December 7, 2006. Ann C. Agnew, Executive Secretary to the Department. [FR Doc. E6-21232 Filed 12-13-06; 8:45 am] BILLING CODE 4150-26-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Information (RFI): Guidance for Prioritization of Pre-pandemic and Pandemic Influenza Vaccine AGENCY: Office of the Secretary, Department of Health and Human Services. ACTION: Notice. SUMMARY: Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be passed between humans. Because humans lack immunity to the new virus, a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the U.S., each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1,000 of those infected. It is projected that a modern pandemic, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the United States alone. Extensive information on Federal government strategic and implementation plans for pandemic flu is available at *http://www.pandemicflu.gov.* A critical part of the United States Government

(USG)strategy to control the spread of a pandemic and reduce its health and societal impact is through the use of vaccines. The U. S. Government is working toward a goal of expanding domestic influenza vaccine surge capacity for the production of pandemic influenza vaccines for the entire population within six months of a pandemic declaration. However, at the beginning of a pandemic, the scarcity of pre-pandemic influenza vaccine and pandemic influenza vaccine (which could include up to two doses) will require that the limited supply be prioritized for distribution and administration. Pre-pandemic vaccine refers to influenza vaccine that is produced against a virus strain that is believed to have pandemic potential and is maintained in a national stockpile. Depending on what influenza strain actually causes the pandemic, stockpiled pre-pandemic vaccine may provide some protection. Total quantities of pre-pandemic vaccines will be limited. Accordingly, the Federal government has initiated a process to provide guidance to assist State and local governments, communities, tribal and territorial governments, and the private sector in defining groups that should be considered for priority access to scarce vaccine. Guidance will be drafted by a Federal interagency task force that will seek information and advice from relevant individual stakeholders, a public engagement process in selected communities across the country, and through this Request for Information (RFI). The Federal government plans to issue draft guidance resulting from this process for public comment before finalization. With this RFI, the Department of Health and Human Services

(HHS)requests input from the public on considerations in developing guidance for prioritization of the distribution and administration of both pre-pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. Specifically, HHS is seeking input on pandemic influenza vaccine prioritization considerations from all interested and affected parties, including but not limited to public health and health care individuals and organizations, as well as those from other sectors of the economy including, for example, travel and transportation, commerce and trade, law enforcement, emergency management and responders, other critical infrastructure sectors and the general public. Previous reports relating to pandemic influenza vaccine prioritization issues are available at *http://www.pandemicflu.gov.* DATES: Responses should be submitted to the Department of Health and Human Services on or before 5 p.m., EDT, January 18, 2007. ADDRESSES: *Instructions for Submitting Comments:* Electronic responses are preferred and may be addressed to *PandemicFlu.RFI@ hhs.gov* . Written responses should be addressed to Department of Health and Human Services, Room 434E, 200 Independence Avenue, SW., Washington, DC 20201, Attention: Pandemic Influenza Vaccine Prioritization RFI. A copy of this RFI is also available on the PandemicFlu.Gov Web site and at *http://www.aspe.hhs.gov/PIV/rfi.* Please follow instructions for submitting responses. The submission of written materials in response to the RFI should not exceed 25 pages, not including appendices and supplemental documents. Responders may submit other forms of electronic materials to demonstrate or exhibit concepts of their written responses. Any information you submit will be made public. Consequently, do not send proprietary, commercial, financial, business confidential, trade secret, or personal information that you do not wish to be made public. *Public Access:* Responses to this RFI will be available to the public in the HHS Public Reading Room, 200 Independence Avenue, SW., Washington, DC 20201. Please call

(202)690-7453 between 9 a.m. and 5 p.m. to arrange access. The RFI and all responses will also be made available on the HHS Web site at *PandemicFlu.Gov.* FOR FURTHER INFORMATION CONTACT: Dr. Ben Schwartz, Office of Public Health and Science,

(404)639-8953. SUPPLEMENTARY INFORMATION: Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be passed between humans. Because humans lack immunity to the new virus, a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the U.S., each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1,000 of those infected. Extrapolating from experience in prior pandemics, it is projected that a modern pandemic, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the United States alone. The goals of the Federal response to an influenza pandemic include to:

(1)Stop, slow, or otherwise limit the spread of the pandemic to the United States;

(2)limit the domestic spread of the pandemic and mitigate the disease, suffering, and death; and

(3)sustain infrastructure and mitigate impact to the economy and functioning of society. A critical part of the U.S. Government strategy to control the spread of a pandemic and reduce its health and societal impact is through the use of vaccines. The U.S. Government is working toward a goal of expanding domestic influenza vaccine surge capacity to ensure the production of pandemic vaccines for the entire population within six months of a pandemic declaration. However, at the beginning of a pandemic, the scarcity of pre-pandemic and pandemic influenza vaccine will require that the limited supply be prioritized for distribution and administration. The Homeland Security Council Implementation Plan for the National Strategy for Pandemic Influenza requires that HHS in coordination with the Department of Homeland Security

(DHS)shall identify lists of personnel and high-risk groups who should be considered for priority access to medical countermeasures, including pre-pandemic and pandemic influenza vaccine. Priority recommendations will reflect the pandemic response goals of limiting mortality and severe morbidity; maintaining critical infrastructure and societal function; diminishing economic impacts; and maintaining national security. Limiting transmission may also be an objective. To accomplish this task a Federal interagency working group has been established to:

(1)Recommend priority groups for pandemic influenza vaccination as guidance for State, local, and tribal pandemic planning; and

(2)recommend priority groups for vaccination with pre-pandemic vaccine as guidance for State, local, and tribal pandemic planning. The working group is co-chaired by HHS and DHS and includes members representing other Federal agencies. The working group is soliciting information from individual stakeholders in a series of meetings. In addition, a series of public engagement meetings will be held across the country to gather further information. This RFI provides an additional opportunity to inform the pandemic vaccine priority development process. In addition, the interagency working group's draft guidance and recommendations will be published in the **Federal Register** for a public comment period before being finalized. Priorities for vaccine use will vary based on pandemic severity as well as the vaccine supply. In a situation where a very limited vaccine supply exists, it will be necessary to narrowly target and efficiently use the available vaccine. With greater availability, it may be feasible to expand priority groups and consider strategies to limit disease transmission. With respect to pre-pandemic vaccines, prioritization must consider the limited available supply and the likelihood that protection will only be partial, depending on how close the pre-pandemic vaccine matches the circulating pandemic virus. Because no single priority list is appropriate for all scenarios and because significant uncertainty is involved, Federal guidance will be developed for multiple contingencies. Information Requested For the purpose of developing pandemic influenza vaccine prioritization guidance, HHS requests input from the public on priorities for allocation of both pre-pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. HHS is interested in receiving comments on factors that should be considered in order to provide guidance on priority groups for pre-pandemic and pandemic vaccines to best achieve national pandemic response goals. As described earlier, the goals of the Federal response to an influenza pandemic include to:

(1)Stop, slow, or otherwise limit the spread of the pandemic to the United States;

(2)limit the domestic spread of the pandemic and mitigate the disease, suffering, and death; and

(3)sustain infrastructure and mitigate impact to the economy and functioning of society. HHS is particularly interested in receiving responses to the following questions: • What objectives, principles, strategies, criteria, assumptions and rationales should be considered in pandemic vaccine prioritization determinations? • What is the relative importance of the three goals described above and what are the associated implications for vaccine prioritization? • Which population group(s) should have priority for receiving pre-pandemic vaccine? Which should have priority for receiving pandemic vaccine? What is the rationale? • How can fairness, equity, efficiency and related principles be reflected in the determination of priority groupings for receipt of pre-pandemic or pandemic vaccine? • For priority groups, how should vaccine be allocated, distributed and administered? Who (Federal, State or local authorities) should determine when and how the vaccine is distributed and administered? Potential Responders HHS invites input from a broad range of individuals and organizations that have interests in pre-pandemic and pandemic vaccine prioritization. Some examples of these organizations include but are not limited to the following: • State and local governments • Advocacy groups and public interest organizations • State and local public health departments • Vaccine manufacturing industry, distributors and related organizations • Health care professional societies and organizations • Police, law enforcement, and public safety organizations • Trade and labor organizations • Emergency management and first responder organizations • Chambers of Commerce and other business representatives • Public utilities • Other critical infrastructure sectors • General Public Dated: December 11, 2006. John O. Agwunobi, Assistant Secretary for Health, Office of Public Health and Science, Department of Health and Human Services. [FR Doc. E6-21282 Filed 12-13-06; 8:45 am] BILLING CODE 4151-05-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-227] Public Health Assessments and Health Consultations Completed July 2006-September 2006 AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from July 2006 through September 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List

(NPL)and includes sites for which assessments or consultations were prepared in response to requests from the public. FOR FURTHER INFORMATION CONTACT: William Cibulas, Jr., Ph.D., Director, Division of Health Assessment and Consultation, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, NE., Mailstop E-32, Atlanta, Georgia 30333, telephone

(404)498-0007. SUPPLEMENTARY INFORMATION: The most recent list of completed public health assessments was published in the **Federal Register** on August 2, 2006 [71 FR 43774]. This announcement is the responsibility of ATSDR under the regulation “Public Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities” [42 CFR part 90]. This rule sets forth ATSDR's procedures for the conduct of public health assessments under section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended by the Superfund Amendments and Reauthorization Act

(SARA)[42 U.S.C. 9604(i)]. Availability The completed public health assessments and health consultations are available for public inspection at the ATSDR Records Center, 1825 Century Boulevard, Atlanta, Georgia (not a mailing address), between 8 a.m. and 4:30 p.m., Monday through Friday except legal holidays. Public health assessments and health consultations are often available for public review at local repositories such as libraries in corresponding areas. Many public health assessments and health consultations are available through ATSDR's Web site at *http://www.atsdr.cdc.gov/HAC/PHA/* . In addition, the completed public health assessments are available by mail through the U.S. Department of Commerce, National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, Virginia 22161, or by telephone at

(800)553-6847. NTIS charges for copies of public health assessments. The NTIS order numbers are listed in parentheses following the site names. Public Health Assessments Completed or Issued Between July 2006, and September 2006, public health assessments were issued for the sites listed below: NPL and Proposed NPL Sites Illinois Ottawa Radiation Areas—(PB2006-114090) Louisiana Gulf States Utilities Company (a/k/a North Ryan Street Facility)—(PB2006-115440) Missouri Annapolis Lead Mine—(PB2006-115491) New Jersey Crown Vantage Landfill Site—(PB2006-113405) Naval Weapons Station Earle (NWSE)—(PB2006-114586) Rolling Knolls Landfill—(PB2006-113406) New York Hudson Technologies, Inc.—(PB2006-101877) Tennessee Evaluation of Potential Exposures to Contaminated Off-Site Groundwater from the Oak Ridge Reservation (USDOE)—(PB2006-114089) White Oak Creek Radionuclide Releases, Oak Ridge Reservation (USDOE)—(PB2006-114587) Wisconsin Scrap Processing Company, Inc. (a/k/a Scrap Processing)—(PB2006-100121) Non-NPL Petitioned Sites California Evaluation of Exposures to Contaminants from the Former ABEX/REMCO Hydraulics Facility—(PB2006-114088) Florida Town and Country Lake Estates—(PB2006-100957) New Mexico Los Alamos National Laboratory, U.S. Department of Energy—(PB2006-115492) Utah Bauer Dump and Tailings Blackhawk Resin Company—(PB2006-114069) West Virginia Reedsville Scattered Foundry Waste CERCLIS Site—(PB2006-115493) Health Consultations Completed or Issued Between July 2006, and September 2006, health consultations were issued for the sites listed below: Alabama Matthews International: York Casket Voluntary Cleanup Site Arizona Evaluation of Water Flows in the Nogales Wash North Indian Bend Wash—Central Ground Treatment Facility Arkansas Private Groundwater Well Quality Near the Transitech, Incorporated Site California Evaluation of Health Studies Possibilities and Limitations at the ABEX/REMCO Hydraulics Facility Hookston Station Site Review and Approval of the Risk Assessment Colorado Schlage Lock Company—Exposure and Health Effects Evaluation of PCE Contamination in Willow Springs Ponds Connecticut Old Southington Landfill Site—Technical Review of the Risk Assessment for Gas Vent Volatile Organic Compound Data Public Health Evaluation of Fish Contamination Data in the Connecticut River and Park River Conduit Florida Altha School Air Monitoring Long's Old Pond—Fish Testing Saufley Field Landfill—Evaluation of Ambient Air Sampling Idaho Evaluation of Air Contaminants in the Treasure Valley Area Evaluation of Selenium in Elk in the Southeast Idaho Phosphate Resource Area Illinois Belvidere Municipal Landfill #1 Bohn Heat Transfer Facility Dixie Auto Salvage Lincoln Limited Landfill Smith-Douglass Iowa Iowa City Former Manufactured Gas Plant Site Tails A Waggin' Pet Resort—Arsenic Soil Contamination Kentucky Martin County Coal Slurry Release Rubbertown Industrial Area Louisiana Bayou Sorrel—Post-Hurricane Groundwater Sampling Evaluation Combustion, Inc.—Post-Hurricane Groundwater Sampling Evaluation Devil's Swamp Lake—A Review of Fish Data Hurricane Response Sampling Assessment for D.L. Mud, Inc. Hurricane Response Sampling Assessment for Gulf Coast Vacuum Services Hurricane Response Sampling Assessment for PAB Oil & Chemical Service, Inc. Hurricane Response Sampling Assessment for the Agriculture Street Landfill Hurricane Response Sampling Assessment for the Southern Shipbuilding Corporation Petro Processors of Louisiana, Inc.—Post-Hurricane Groundwater Sampling Evaluation Maine Contaminant Accumulation Potential in Plants and Animals Used by the Aroostook Band of Micmac Indians at the Former Loring Air Force Base Holtrachem Manufacturing Company Massachusetts Environmental Data Review for Witchcraft Heights Elementary School and Nearby Properties Former Zonolite Facility—Wemelco Way Michigan I-75/Caniff Area (Hamtramck) Lead Contamination (a/k/a “Grand Haven” Area (Hamtramck) Lead Contamination) Little Black Creek Sediments Little Black Creek Sediments—Floodplain Soil Sampling Results Petersburg Mercury Site Minnesota Former Park Rapids Dump Off-Site Soils: CMC Heartland Partners Lite Yard Site St. Louis River Sediments: U.S. Steel Site—Dioxin and Polycyclic Aromatic Hydrocarbon Chemical Signatures (Fingerprints) in Sediments St. Louis River Sediments: U.S. Steel Site—Technical Review of Discrepancies in 2002 Lacer Induced Fluorescence Data, and 2003 and 2004 Analytical Data Missouri Brewer Brothers Petroleum Bulk Plant Former Cardwell Memorial Hospital Former Zonolite Company/W.R. Grace Facility—St. Louis Sherrill Mini Mart/Health Clinic Nevada Yerington Anaconda Mine Site (a/k/a Anaconda Mine) New Hampshire Bear Brook Villa Cancer Incidence: Residents of Claremont, Sullivan County, New Hampshire (Wheelabrator-Claremont Site) New Jersey Adrow Chemical Company Site Kiddie Kollege—Mercury Exposure Investigation Matteo & Sons (a/k/a Matteo Iron and Metal Site) New York Mariners Marsh Park—Area of Concern North Carolina Payne Road Solvents Sigmon's Septic Tank Service—Evaluation of Surface Water Data Ohio Fair Oak Park Oregon North Morrow and Northwest Umatilla Perchlorate Area Salem-Keizer School District—3M Flooring Pennsylvania Former W.R. Grace/Zonolite Co. Facility—Investigation of Nearby Play Area Waymart Spill Site Tennessee Clover Creek Workers (a/k/a Velsicol Chemical Corp.) Cypress Creek Sub-Area III Glover Site (a/k/a Tennessee Products) Skyline Drive Dump Texas Cox Road Dump Site—Barium Health Concern Tenaha Wood Treating Tronox LLC, Texarkana Facility Washington BSB Diversified/Hexcel Corporation—Evaluation of Ground Water Contamination DNR Triangle Gravel Pit Gilbert Elementary School—Evaluation of Soil Contamination Holmes Harbor Lincoln Elementary School—Evaluation of Soil Contamination Manson Elementary School—Evaluation of Soil Contamination Naches Valley Intermediate School—Evaluation of Soil Contamination Robertson Elementary School—Evaluation of Soil Contamination Washington Elementary School—Evaluation of Soil Contamination Wisconsin Badger Army Ammunition Plant—Dinitrotoluene in Private Wells Econocare Cleaners Vapor Intrusion Investigation Redi-Quik Dry Cleaners—Vapor Intrusion in a Private Residence Dated: December 8, 2006. Kenneth Rose, Acting Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E6-21263 Filed 12-13-06; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-0641] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at 404-639-4604 or send a e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Background and Brief Description Descriptive Epidemiology of Missed or Delayed Diagnoses for Conditions Detected by Newborn Screening—(OMB No. 0920-0641)—Revision—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Every state in the United States and Washington, DC, has a public health program to test newborn babies for congenital metabolic and other disorders through laboratory testing of dried blood spots. These programs screen for between four and 36 different conditions including phenylketonuria

(PKU)and congenital hypothroidism, with testing performed in both state laboratories and private laboratories contracted by state health departments. The screening process or system is broader than the state public health newborn screening program, which is composed only of the laboratory and follow-up personnel. Most children born with metabolic disease are identified in a timely manner and within the parameters defined by the newborn screening system of each state. These children are referred for diagnosis and treatment. However, some cases are not detected at all or the detection comes too late to prevent harm. These “missed cases” often result in severe morbidity such as mental retardation or death. In this project, we will continue to collect information about missed or delayed diagnoses in order to update and expand a previous epidemiological study of missed cases of two disorders published in 1986. We will assess the number of cases of each disorder missed, and the potential reasons for the miss and legal outcomes. Data will be collected by asking state public health laboratory directors, newborn screening laboratory managers, follow-up coordinators, specialists at metabolic clinics, and parent groups with an interest in newborn screening for information regarding missed cases. An estimated 135 remaining respondents will participate in our study by completing one or two short questionnaires that ask for information regarding the details of any missed or delayed cases of which they are aware. The survey will highlight procedures and actions taken by states and other participants in newborn screening systems to identify causes of missed cases and to modify policies and procedures to prevent or minimize recurrences. The information gleaned from this study may be used to help craft changes in the screening protocols that will make the process more organized and efficient and less likely to fail an affected child. Respondent burden is approximately 3 minutes for the State Form and 10 minutes for the Case Report Form. There are no costs to the respondents other than their time. The total estimated annual burden hours are 28. Estimated Annualized Burden Hours Respondents Form name Number of respondents Number of responses per respondent Average burden (hours) per response Total burden (hours) Director, State Newborn Screening Laboratory State Form 25 1 3/60 1.3 Case Report Form 25 1 10/60 4.2 Follow-up State Coordinator State Form 25 1 3/60 1.3 Case Report Form 25 1 10/60 4.2 Metabolic Clinic Employee State Form 60 1 3/60 3 Case Report Form 60 1 10/60 10 Parent Advocate Case Report Form 5 1 10/60 0.8 Parent Case Report Form 20 1 10/60 3.3 Dated: December 8, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 06-9723 Filed 12-13-06; 8:45 am]

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